World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 3 August 2015
Main ID:  NCT01880307
Date of registration: 07/06/2013
Prospective Registration: Yes
Primary sponsor: Erasmus Medical Center
Public title: Infliximab Top-down in Pediatric Crohn ITSKids
Scientific title: Infliximab Top-down Study in Kids With Crohn's Disease
Date of first enrolment: January 2013
Target sample size: 13
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT01880307
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Italy Netherlands
Contacts
Name:     Lissy Ridder, de, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Erasmus Medical Center
Key inclusion & exclusion criteria

Inclusion Criteria:

Children (age 3-17 years, both male and female) with new-onset, untreated CD with
moderate-to-severe disease activity assessed by a wPCDAI >40 will be eligible for
inclusion after a diagnosis of CD was made based on the Porto criteria.

Exclusion Criteria:

Patients with the following characteristics will be excluded: immediate need for surgery,
symptomatic stenosis or stricture in the bowel due to scarring, active perianal fistulas,
severe co-morbidity, severe infection such as sepsis or opportunistic infections, positive
stool culture, positive Clostridium difficile assay, positive tuberculin test or a chest
radiograph consistent with tuberculosis or malignancy, those already started with CD
specific therapy.



Age minimum: 3 Years
Age maximum: 17 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: Azathioprine
Drug: Infliximab
Drug: Prednisolon
Primary Outcome(s)
Clinical remission without need for additional CD related therapy or surgery [Time Frame: 52 weeks]
Secondary Outcome(s)
Adverse event rates [Time Frame: 260 weeks]
Adverse events rates [Time Frame: 52 weeks]
Clinical response and remission rate [Time Frame: 10 weeks]
Cumulative therapy use [Time Frame: 260 weeks]
Cumulative therapy use [Time Frame: 52 weeks]
Growth [Time Frame: 10 and 52 weeks]
Long-term yearly clinical remission, response and mucosal healing (calprotectin) rates [Time Frame: 260 weeks]
Long-term yearly remission rates without need for additional CD related therapy or surgery [Time Frame: 260 weeks]
Mucosal healing [Time Frame: 10 and 52 weeks]
Therapy failure rates over time [Time Frame: 52 weeks]
Yearly number of flares [Time Frame: 260 weeks]
Secondary ID(s)
2012-000645-13
2014-005702-37
NL39202.078.12
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University Hospital, Brussels
University of Roma La Sapienza
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history